In vitro diagnostic (IVD) products pertaining to medical device are defined as reagents, instruments, calibrators and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, an observation of after-cured situation, in order to predicate or prevent disease. Such products can be used individually or used in combination with other instruments, facilities or systems. It must be pointed out that IVD products those adopt radionuclide label or intended for use in blood kinship screening, such products pertaining to drugs administration are not included here. In vitro diagnostic labeling requirements are located in <Guiding Principle for the Instructions of In Vitro Diagnostic Reagents>.
This section contains the basis requirements for manual/package insert format of in vitro diagnostic reagents as follows:
- 【name】: shall be the Chinese common name, foreign language designation can be used if necessary.
- 【packing specification】: indicate the number of samples those are able to be used for testing.
- 【intended use】: explain the intended purpose and relevant background.
- 【inspection mechanism】: specify the inspection mechanism and methods through texts or diagrams if necessary.
- 【main composition】: list compositions those contained or not contained (but required for test) in the product and calibrators.
- 【storage condition and validity term】: specify the storage condition and validity term of the product.
- 【applied instrument】: indicate the applied instrument, model and relevant information.
- 【specimen requirement】: include applicable specimen, special cautions, required anticoagulation and storage, transportation methods to ensure the stability of specimen.
- 【inspection method】: explain the reagent preparation, test requirement, calibration procedure, quality control procedure and calculation of the results.
- 【positive estimate value or reference interval】: show the value or interval and give the simple determination.
- 【explanation for inspection consequence】: factors can influence the test result shall be discussed in this section.
- 【limitation of the inspection method】: summarize the limitation of the inspection method.
- 【property】: state the main properties of the product.
- 【cautions】: significant cautions such as “this product is only used for in vitro diagnostic “must be specified here.
- 【explanation for marks】: explain the meaning of diagrams or symbols.
- 【reference】: list cited reference.
- 【basic information】: include name, address, contact information, manufacture location etc.
- 【registration serial number/record number/technical requirement】
- 【instruction manual approval and revision date】: indicate the approval date of the instruction manual (package insert), if there was ever a change for the manual, the revision date shall be explained as well.
Some of above requirements can be absent if it is not applicable for the product.
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